BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGID INJECTION NEEDLE-STRAIGHT

    MDR report key: 961467 · Received December 7, 2007

    Report

    Report Number
    2135225-2007-00013
    Event Type
    Malfunction
    Date Received
    December 7, 2007
    Date of Event
    October 5, 2006
    Report Date
    December 6, 2007
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THE REPORTED LOT, 1003298, MET ALL SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE INDICATES THE NEEDLE CANNULA HAD BEEN BENT IN A SLIGHT ARC. THERE IS NOTICEABLE DRIED PRODUCT IN BOTH THE NEEDLE HUB AND IN THE CANNULA TIP. THE BREAK PATTERN LOOKS LIKE IT HAD BEEN BENT IN TWO DIRECTIONS. IT IS NOT RECOMMENDED TO BEND THE NEEDLE TIP OR CANNULA FOR USE. THERE WAS NO PT HARM REPORTED, SINCE THIS EVENT OCCURRED DURING PRIMING AND DID NOT INVOLVE CONTACT WITH THE PT. UPON REVIEW OF THE FDA MED DEVICE REPORT DECISION TREE AT BIOFORM MEDICAL, A DECISION WAS MADE TO REPORT THIS EVENT BASED ON A CHANCE OF CAUSING INJURY IF THE EVENT WERE TO RECUR DURING USE.

    Description of Event or Problem · 1

    DR. REPORTED THAT A NEEDLE JAM OCCURRED WHILE PRIMING THE TRANS-ORAL NEEDLE FOR A RADIESSE VOCAL FOLD INJECTION. THE PHYSICIAN TRIED TO FLUSH THE NEEDLE WITH STERILE WATER. IT WAS AT THIS TIME, THAT THE PHYSICIAN NOTICED THE NEEDLE TIP HAD BROKEN FROM THE CANNULA. SINCE THE EVENT OCCURRED OUTSIDE THE PT, THERE WERE NO PT COMPLICATIONS REPORTED FROM THIS DEVICE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGID INJECTION NEEDLE-STRAIGHT INJECTION NEEDLE GAA BIOFORM MEDICAL 1003298

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other